Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease
Public ClinicalTrials.gov record NCT02760407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving but not fully responding to treatment with methotrexate (MTX). The primary objective of this study was to evaluate the efficacy of OKZ 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active RA inadequately controlled by MTX therapy. The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX therapy.
Study identification
- NCT ID
- NCT02760407
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,648 participants
Conditions and interventions
Conditions
Interventions
- Olokizumab 64mg q4w Drug
- Olokizumab 64mg q2w Drug
- Adalimumab 40mg q2w Drug
- Placebo q2w Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 6, 2016 (Actual)
- Primary completion
- Aug 2, 2019 (Actual)
- Completion
- Nov 5, 2019 (Actual)
- Last update posted
- Sep 21, 2023
2016 – 2019
United States locations
- U.S. sites
- 64
- U.S. states
- 27
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates, P.C. | Mesa | Arizona | 85210 | — |
| Arizona Arthritis & Rheumatology Associates, P.C. | Phoenix | Arizona | 85032 | — |
| Arizona Arthritis & Rheumatology Research, PLLC | Sun City | Arizona | 85351 | — |
| Medvin Clinical Research | Covina | California | 91722 | — |
| TriWest Research Associates | El Cajon | California | 92020 | — |
| MD Med Corp. | Hemet | California | 92543 | — |
| Valerius Medical Group | Los Alamitos | California | 90720-5403 | — |
| Rheumatology Center of San Diego | San Diego | California | 92128 | — |
| East Bay Rheumatology Medical Group, Inc. | San Leandro | California | 94578 | — |
| Pacific Arthritis Center Medical Grpoup | Santa Maria | California | 93454 | — |
| Inland Rheumatology Clinical Trials | Upland | California | 91786 | — |
| Center for Rheumatology Research | West Hills | California | 91607 | — |
| Medvin Clinical Research | Whittier | California | 90602 | — |
| Denver Arthritis Clinic | Denver | Colorado | 80230 | — |
| New England Research Associates LLC | Bridgeport | Connecticut | 6606 | — |
| Javed Rheumatology Associates | Newark | Delaware | 19713 | — |
| RASF - Clinical Research Center | Boca Raton | Florida | 33486 | — |
| Reliable Clinical Research, LLC | Hialeah | Florida | 33012 | — |
| Pharmax Research Clinic, Inc. | Miami | Florida | 33126 | — |
| Medical Research Center of Miami | Miami | Florida | 33134 | — |
| Omega Research Consultants | Orlando | Florida | 32810 | — |
| Arthritis Research | Palm Harbor | Florida | 34684 | — |
| Family Clinical Trials, LLC. | Pembroke Pines | Florida | 33026 | — |
| AdventHealth Medical Group, PA | Tampa | Florida | 33614 | — |
| Lovelace Scientific Resources, Inc. | Venice | Florida | 34292 | — |
| Arthritis Center of North Georgia | Gainesville | Georgia | 30501 | — |
| Marietta Rheumatology Associates, PC | Marietta | Georgia | 30060 | — |
| Institute of Arthritis Research | Idaho Falls | Idaho | 83404 | — |
| Springfield Clinic, LLP | Springfield | Illinois | 62702 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| Graves Gilbert Clinic | Bowling Green | Kentucky | 42101 | — |
| The Arthritis & Diabetes Clinic, Inc. | Monroe | Louisiana | 71203 | — |
| Klein and Associates, M.D., P.A. | Hagerstown | Maryland | 21740 | — |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | — |
| AA MRC LLC Ahmed Arif Medical Research Center | Grand Blanc | Michigan | 48439 | — |
| North MS Medical Clinics, Inc. | Tupelo | Mississippi | 38801 | — |
| Glacier View Research Instutute-Rheumatology | Kalispell | Montana | 59901 | — |
| Physician Resrch Collaboration | Lincoln | Nebraska | 68516 | — |
| Arthritis & Osteoporosis Associates, PA | Freehold | New Jersey | 07728 | — |
| NYU Langone ambulatory care | Brooklyn | New York | 11201 | — |
| Medication Management, LLC | Greensboro | North Carolina | 27408 | — |
| Cape Fear Arthritis Care | Leland | North Carolina | 28451 | — |
| Trinity Medical Group | Minot | North Dakota | 58701 | — |
| STAT Research, Inc. | Dayton | Ohio | 45417 | — |
| Clinical Research Source, Inc. | Toledo | Ohio | 43606 | — |
| Health Research of Oklahoma, PLLC | Oklahoma City | Oklahoma | 73103 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Altoona Center for Clinical Research, P.C. | Duncansville | Pennsylvania | 16635 | — |
| Low Country Rheumatology, PA | Summerville | South Carolina | 29486 | — |
| Amarillo Center for Clinical Research | Amarillo | Texas | 79124 | — |
| Austin Regional Clinic, P.A. | Austin | Texas | 78731 | — |
| Accurate Clinical Management LLC | Baytown | Texas | 77521 | — |
| Pioneer Research Solutions, Inc. | Beaumont | Texas | 77702 | — |
| Precision Comprehensive Clinical Research Solutions | Grapevine | Texas | 76034 | — |
| Rheumatology Clinic of Houston, P.A. | Houston | Texas | 77065 | — |
| Accurate Clinical Research | Houston | Texas | 77084 | — |
| Accurate Clinical Mangemnt LLC | Houston | Texas | 77089 | — |
| Accurate Clinical Research, Inc. | Houston | Texas | 77089 | — |
| Advanced Rheumatology of Houston | Houston | Texas | 77382 | — |
| Accurate Clinical Research, Inc. | League City | Texas | 77573 | — |
| Endocrinology, Internal Medicine | Lubbock | Texas | 79410 | — |
| Dr. Alex De Jesus Rheumatology, P.A. | San Antonio | Texas | 78229 | — |
| DM Clinical Research | Tomball | Texas | 77375 | — |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 139 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02760407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2023 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02760407 live on ClinicalTrials.gov.